The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03085888|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2017
Last Update Posted : May 1, 2019
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||99481 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection|
|Actual Study Start Date :||February 28, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2025|
This is a prospectively enrolling cohort study with a pre-specified molecular analysis plan. A stratified case-cohort design will be employed to select cancer cases and non-cancer subjects who will be assayed. All cases of cancer (breast and non-breast cancer) will be selected. A random subset of the overall study cohort will also be selected.
- Diagnosis of invasive cancer, including hematologic malignancies within one year after the first study blood draw. [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]Clinically annotated plasma samples from participants will undergo high-intensity sequencing to characterize cfNA profiles.
- Diagnosis of invasive cancers, including hematologic malignancies, that occur between 12 and 24 months after the first study blood draw, and cancer-specific mortality. [ Time Frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months ]Clinically annotated plasma samples from participants will undergo high-intensity sequencing to characterize cfNA profiles.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085888
Show 37 Study Locations
|Study Director:||Brian Allen, MS||GRAIL, Inc.|
|Study Director:||Anne-Renee Hartman, MD||GRAIL, Inc.|